Top Eight Regulatory News Stories This Week

Regulatory Roundup: Top News Stories – Week Ending June 2, 2017

There was a lot of regulatory activity coming out of Europe this week along with a few announcements in the US. Here are a few of the top stories for regulatory professionals to follow:

  1. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its May 2017 meeting. This includes Novartis’s Zykadia for metastatic non-small cell lung cancer and LEO Pharma’s brodalumab plaque psoriasis treatment among others. Full Story Here
  2. Pfizer’s meningococcal group B vaccine Trumenba won European approval for prevention of meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in adolescents over 10 years and adults. The approval pits Trumenba directly against GlaxoSmithKline’s Bexsero for serogroup B, which has been approved in Europe for years. Full Story Here
  3. Little-known Emmaus Life Sciences won an FDA panel vote favoring an approval by 10-3 for sickle cell disease. This sets it on a course for a likely approval by the PDUFA date of July 7. Full Story Here
  4. The FDA has rejected Sunovion’s experimental COPD combination product. Sunovion released a statement saying that they will work with the FDA to determine an appropriate path forward and that they are “committed to bringing this innovative therapy to COPD patients in the U.S. as quickly as possible.” Full Story Here
  5. Eli Lilly’s phase 3 trial of ramucirumab in combination with docetaxel succeeded by meeting its primary endpoint of significantly improving progression-free survival for urothelial cancer. Lilly said that it would wait for the overall survival results for this combination before applying for regulatory approvals as therapy for urothelial carcinoma. Those results are expected to be ready by mid-2018. Full Story Here
  6. Teva Pharmaceutical Industries has reported positive results from a Phase III study for its migraine drug fremanezumab. Based on these results, Teva plans to submit a BLA to the FDA for fremanezumab later this year. Full Story Here
  7. British drugmaker Indivior Plc said it applied for a new drug application to the U.S. FDA to market its drug to treat opioid use disorder Full Story Here
  8. GSK has submitted a two-drug regimen for patients with HIV to the FDA and EMA and plans to use a Priority Review Voucher in the US to speed up the approval process: Full Story Here

In other news…

Mallinckrodt is rumored to be exploring the sale of its generic drugs business which has been a drag on the rest of the company. This divestment would complete the company’s gradual shift away from generic drugs toward branded specialty pharmaceuticals and this deal could fetch as much as $2 billion: Full Story Here

The new FDA commissioner Dr. Scott Gottlieb indicated that the agency can help tackle high drug prices by approving more generic drug applications. He also wants to make it more difficult for drugs that are off patent to jack up prices when they don’t face any competition. Full Story Here

Despite all the negative news about drug prices, a new report from Reputation Institute paints a positive perception of the pharma industry by the general public. Across all responders, 71.8% had positive perceptions of the industry, up from 68.2% the year prior. In fact, pharma’s reputation has increased each year since at least 2014, when it clocked in at 65.8%. AbbVie leads the industry with a 74.5% positive perception from the general public, according to the study, while Novo Nordisk and Takeda round out the top three — scoring at 74% and 73.8%, respectively.  Full Story Here

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